Trial Outcomes & Findings for A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02) (NCT NCT00830791)

Results Overview

Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour creatinine clearance (CLCR) of \> 50 to 80 mL/min/1.73m\^2.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

72 Hours Post-Dose

Results posted on

2015-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	MK-0941 20 mg Mild Renal Insufficiency MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.	Control + MK-0941 20 mg Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.	MK-0941 20 mg Moderate Renal Insufficiency MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.	Control + 20 mg MK-0941 Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
Overall Study STARTED	8	8	8	8
Overall Study COMPLETED	8	8	8	8
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-0941 20 mg Mild Renal Insufficiency n=8 Participants MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.	Control + MK-0941 20 mg n=8 Participants Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.	MK-0941 20 mg Moderate Renal Insufficiency n=8 Participants MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.	Control + 20 mg MK-0941 n=8 Participants Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.	MK-0941 5 mg Severe Renal Insufficiency MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.	Control + MK-0941 5 mg Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	—	—	0 participants n=8 Participants
Age, Categorical Between 18 and 65 years	6 participants n=5 Participants	6 participants n=7 Participants	7 participants n=5 Participants	7 participants n=4 Participants	—	—	26 participants n=8 Participants
Age, Categorical >=65 years	2 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	—	—	6 participants n=8 Participants
Gender Female	6 participants n=5 Participants	6 participants n=7 Participants	5 participants n=5 Participants	5 participants n=4 Participants	—	—	22 participants n=8 Participants
Gender Male	2 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	—	—	10 participants n=8 Participants

PRIMARY outcome

Timeframe: 72 Hours Post-Dose

Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour creatinine clearance (CLCR) of \> 50 to 80 mL/min/1.73m\^2.

Outcome measures

Outcome measures
Measure	MK-0941 20 mg n=8 Participants MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).	Control + MK-0941 20 mg n=8 Participants Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls	1481.42 nM per Hour Interval 1163.05 to 1886.93	1553.50 nM per Hour Interval 1241.46 to 1943.98

PRIMARY outcome

Timeframe: 72-Hours Post-Dose

Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2.

Outcome measures

Outcome measures
Measure	MK-0941 20 mg n=8 Participants MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).	Control + MK-0941 20 mg n=8 Participants Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among With Moderate Renal Insufficiency vs Matched Controls	2084.00 nM per Hour Interval 1592.63 to 2726.99	1278.83 nM per Hour Interval 987.34 to 1656.37

PRIMARY outcome

Timeframe: 72-Hours Post-Dose

Population: This study was discontinued early and participants were not treated with the 5 mg dose.

Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency taking a single oral dose of 5 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72-Hours Post-Dose

Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2.

Outcome measures

Outcome measures
Measure	MK-0941 20 mg n=8 Participants MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).	Control + MK-0941 20 mg n=8 Participants Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls	401.39 nM Interval 230.68 to 698.43	543.45 nM Interval 325.26 to 908.0

SECONDARY outcome

Timeframe: 72-Hours Post-Dose

Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2.

Outcome measures

Outcome measures
Measure	MK-0941 20 mg n=8 Participants MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).	Control + MK-0941 20 mg n=8 Participants Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls	499.12 nM Interval 368.13 to 676.74	438.57 nM Interval 327.23 to 587.79

SECONDARY outcome

Timeframe: 72-Hours Post-Dose

Population: This study was discontinued early and participants were not treated with the 5 mg dose.

Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72-Hours Post-Dose

Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2.

Outcome measures

Outcome measures
Measure	MK-0941 20 mg n=8 Participants MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).	Control + MK-0941 20 mg n=8 Participants Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls	1.00 Hours Interval 0.5 to 1.0	0.50 Hours Interval 0.5 to 2.0

SECONDARY outcome

Timeframe: 72-Hours Post-Dose

Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2.

Outcome measures

Outcome measures
Measure	MK-0941 20 mg n=8 Participants MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).	Control + MK-0941 20 mg n=8 Participants Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls	0.75 Hours Interval 0.5 to 4.0	0.50 Hours Interval 0.5 to 2.0

SECONDARY outcome

Timeframe: 72-Hours Post-Dose

Population: This study was discontinued early and participants were not treated with the 5 mg dose.

Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72-Hours Post-Dose

T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of \> 50 to 80 mL/min/1.73m\^2.

Outcome measures

Outcome measures
Measure	MK-0941 20 mg n=8 Participants MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).	Control + MK-0941 20 mg n=8 Participants Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
Time to Apparent Half Life (T 1/2) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls	19.02 Hours Standard Deviation 5.45 • Interval 5.45 to 5.45	15.75 Hours Standard Deviation 7.12 • Interval 7.12 to 7.12

SECONDARY outcome

Timeframe: 72-Hours Post-Dose

T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2.

Outcome measures

Outcome measures
Measure	MK-0941 20 mg n=8 Participants MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).	Control + MK-0941 20 mg n=8 Participants Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
T 1/2 After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls	13.59 Hours Standard Deviation 4.90 • Interval 4.9 to 4.9	11.92 Hours Standard Deviation 5.70 • Interval 5.7 to 5.7

SECONDARY outcome

Timeframe: 72-Hours Post-Dose

Population: This study was discontinued early and participants were not treated with the 5 mg dose.

T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2.